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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03564145
Other study ID # SGT-54-07
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 12, 2018
Est. completion date November 13, 2019

Study information

Verified date December 2021
Source Sol-Gel Technologies, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).


Description:

This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.


Recruitment information / eligibility

Status Terminated
Enrollment 547
Est. completion date November 13, 2019
Est. primary completion date November 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study. 2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
S5G4T-1
Once a day topical cream

Locations

Country Name City State
United States Sol-Gel Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Sol-Gel Technologies, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (non-serious) regardless of causality is located in 'Reported Adverse Events' Section. Baseline up to Week 52
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